Rate of platelet toxicities (i.e. platelet count less than 20,000), graded according to the National Cancer Institute Common Toxicity Criteria version 3.0

Change in hearing levels, if any, at the higher frequencies in the standard testing range (4000 and 8000 Hz), and at higher frequencies above standard testing (9000 to 16000 Hz) based on American Speech-Language-Hearing Association criteria

Incidence of toxicity graded according to Common Toxicity Criteria (CTC) (Phase I)

Maximum tolerated dose of lenalidomide and CHOEP, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)

(and 4 more...)

54

All

18 Years and older (Adult, Senior)

NCT02561273

511-14NCI-2015-00088RV-CL-PTCL-PI-003858P30CA036727

October 2015

October 2020

October 2021

September 28, 2015

July 11, 2017

City of Hope Comprehensive Cancer CenterDuarte, California, United States

Stanford Cancer InstitutePalo Alto, California, United States

University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado, United States

To determine if pentostatin + rituximab and bendamustine + rituximab are each associated with adequate response rates (ORR=PR+CR) in patients with relapsed HCL, and, if so, to select which combination is likely to be superior.

MTD defined as the dose of carfilzomib added to standard R-ICE chemotherapy which, if exceeded, would put the patient at an undesirable risk of medically unacceptable dose-limiting toxicities (Phase I)

Complete response rate according to the International Working Group Response criteria as reported by the revised Cheson criteria

Change in National Institutes of Health (NIH) global score of chronic graft-versus-host disease (GVHD) defined by using the National Institutes of Health (NIH) consensus criteria for assessment of chronic graft-versus-host disease (GVHD) severity

(and 5 more...)

12

All

18 Years and older (Adult, Senior)

NCT02337517

NCI-2014-02672IIT 9664845849664P30CA042014

September 8, 2015

August 1, 2020

January 13, 2015

May 10, 2018

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan, United States

Huntsman Cancer Institute/University of UtahSalt Lake City, Utah, United States